Sunscreen

Product NDC: 61010-6103
11-digit product format: 610106103
Labeler code: 61010
Product ID: 61010-6103_10dfe53b-4cdd-c203-e063-6294a90af360
Type: HUMAN OTC DRUG
Nonproprietary name: Homosalate, Octinoxate, Octisalate, Oxybenzone
Dosage form: LOTION
Route: TOPICAL
Labeler: Safetec of America, Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-03-13
Substance: HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength: 6; 7.5; 5; 5 mg/g; mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Sunscreen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HOMOSALATE	6 mg/g
OCTINOXATE	7.5 mg/g
OCTISALATE	5 mg/g
OXYBENZONE	5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V06SV4M95S	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
95OOS7VE0Y	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
754186c8-3c88-40a0-a4e3-35e3ea9d1b4c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61010-6103-0	Sunscreen	3.5 g in 1 PACKET	LOTION	3.5	6
61010-6103-1	Sunscreen	25 in 1 BOX	LOTION	25	6
61010-6103-2	Sunscreen	2 g in 1 PACKET	LOTION	2	6
61010-6103-3	Sunscreen	25 in 1 BOX	LOTION	25	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Homosalate	ACTIVE INGREDIENT	V06SV4M95S	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
Homosalate	ACTIVE MOIETY	V06SV4M95S	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
Octisalate	ACTIVE MOIETY	4X49Y0596W	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
diazolidinyl urea	INACTIVE INGREDIENT	H5RIZ3MPW4	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
edetate sodium	INACTIVE INGREDIENT	MP1J8420LU	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
polyoxyl 40 stearate	INACTIVE INGREDIENT	13A4J4NH9I	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
povidone K30	INACTIVE INGREDIENT	U725QWY32X	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
water	INACTIVE INGREDIENT	059QF0KO0R	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-6103	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [SAFETEC OF AMERICA, INC.]	6	Current NDC, Legacy NDC, 4 package rows	20240214_754186c8-3c88-40a0-a4e3-35e3ea9d1b4c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 51 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mentholatum Natural Ice Original	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	29220eaa-87cb-4ebe-87db-d36288b3a9e4	2026-03-24	Warnings	Exact identifier application number: M020
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Amazon.com Services LLC	f54c617f-794e-413b-b898-4a06622b4bee	2026-03-24	Warnings, Adverse reactions	Exact identifier application number: M020
VITAL PERFECTION UPLIFTING AND FIRMING ADVANCED DAY	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE	Shiseido Americas Corporation	7b2d15c1-b9e1-4347-b138-9883f78822b3	2026-03-24	Warnings	Exact identifier application number: M020
Sunscreen SPF 50	SUNSCREEN SPF 50	Guangzhou Ariel Biotech Co., Ltd.	4dd05620-30a3-9cea-e063-6294a90af18b	2026-03-24	Warnings	Exact identifier application number: M020
Sunscreen SPF 50	SUNSCREEN SPF 50	Guangzhou Ariel Biotech Co., Ltd.	4dd1b722-4448-9675-e063-6294a90a5f4f	2026-03-24	Warnings	Exact identifier application number: M020
Sky and Sol Face and Body Sunscreen SPF30	NON- NANO ZINC OXIDE	Delta Ecommerce LLC	2dda185c-6ff8-953d-e063-6394a90acc53	2026-03-24	Warnings	Exact identifier application number: M020
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREEN	ZINC OXIDE	ENS KOREA Co., Ltd.	34f9688d-efa1-1d3f-e063-6294a90ab127	2026-03-23	Warnings	Exact identifier application number: M020
HALORINNA SUN-SCREEN TRAVEL SPF50	SUN SCREEN	Guangdong Bisutang Biotechnology Co., LTD	4dade579-ce77-eea5-e063-6394a90ad46a	2026-03-23	Warnings	Exact identifier application number: M020
TIRTIR SUN BOUNCY GLOW LIP BALM SPF30 - 01 HAZY MAUVE	ZINC OXIDE	TIRTIR USA Inc.	4c92db00-59f1-ac02-e063-6394a90a7cf1	2026-03-23	Warnings	Exact identifier application number: M020
Zinc Oxide 20%	SUNSCREEN SPF 50	The Soleil Group, LLC	27d20573-0b6b-4d4b-94ca-69b476a883a7	2026-03-23	Warnings	Exact identifier application number: M020
Babo Botanicals Hydrating Milk Mineral Sunscreen SPF 30	ZINC OXIDE	Babo Botanicals, Inc.	4db37efb-2d37-7428-e063-6394a90a10e4	2026-03-23	Warnings	Exact identifier application number: M020
All Good Mineral Sport Sunscreen Butter	ZINC OXIDE	Elemental Herbs, Inc.	ff334e9c-dd12-92bc-e053-6394a90aa24b	2026-03-23	Warnings	Exact identifier application number: M020
All Good Tinted Mineral Sunscreen Butter SPF 50	ZINC OXIDE	Elemental Herbs, Inc.	fe2bf779-e8b3-933f-e053-6394a90a369f	2026-03-23	Warnings	Exact identifier application number: M020
ULTRA SOOTHER DRY-TOUCH SUNSCREEN	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	skinnplus	4dbc1035-c41c-308c-e063-6394a90a36c4	2026-03-23	Warnings	Exact identifier application number: M020
Daily Defense Mineral Sunscreen Serum Broad Spectrum SPF 33	ZINC OXIDE	Eva's Esthetics	0dd7cba3-bc74-4ec1-bd4a-a2f3ed533fc7	2026-03-23	Warnings	Exact identifier application number: M020
MELAO Rice Probiotics Sunscreen	ZINC OXIDE,ETHYLHEXYL SALICYLATE,ETHYLHEXYL METHOXYCINNAMATE	Guangdong Aimu Biological Technology Co., Ltd	4ccaa734-83c1-611b-e063-6294a90ab3bf	2026-03-21	Warnings	Exact identifier application number: M020
Vacation Lip Trips Desserts Pineapple Upside Down Cake	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation Inc.	69022828-8226-4977-a2ca-ad8e16793a59	2026-03-20	Warnings	Exact identifier application number: M020
VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation Inc.	c7794831-52d1-4d80-936d-44af18ae0472	2026-03-20	Warnings	Exact identifier application number: M020
YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen	ZINC OXIDE	CA-Botana International	4d74a36c-ff68-afd9-e063-6394a90a08f8	2026-03-20	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	468d4ed2-e616-aaaf-e063-6294a90af37a	2026-03-20	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61010-6103-0	61010610300	3.5 g in 1 PACKET	3.5 g					Historical
61010-6103-1	61010610301	25 PACKET in 1 BOX (61010-6103-1) / 3.5 g in 1 PACKET (61010-6103-0)	25 packet	2007-03-13	0000-00-00	No	No	Current
61010-6103-2	61010610302	2 g in 1 PACKET	2 g					Historical
61010-6103-3	61010610303	25 PACKET in 1 BOX (61010-6103-3) / 2 g in 1 PACKET (61010-6103-2)	25 packet	2018-07-01	0000-00-00	No	No	Current